Opinion on the re-evaluation of lecithins (E 322) as a food additive in foods for infants below 1... more Opinion on the re-evaluation of lecithins (E 322) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as food additive for uses in foods for all population groups EFSA Panel on Food Additives and Flavourings (FAF),
Opinion on the re-evaluation of pectin (E 440i) and amidated pectin (E 440ii) as food additives i... more Opinion on the re-evaluation of pectin (E 440i) and amidated pectin (E 440ii) as food additives in foods for infants below 16 weeks of age and follow-up of their re-evaluation as food additives for uses in foods for all population groups EFSA Panel on Food Additives and Flavourings (FAF),
No data are available on insulin clearance (ClI) trends during the pubertal transition. The aim o... more No data are available on insulin clearance (ClI) trends during the pubertal transition. The aim of this study was to investigate in 973 youths with obesity whether ClI in fasting and post-oral glucose challenge (OGTT) conditions varies at the pubertal transition in relation to the severity of obesity and the presence of steatosis liver disease (SLD). The severity of obesity was graded according to the Centers for Disease Control. SLD was graded as absent, mild and severe based on alanine amino transferase levels. ClI was defined as the molar ratio of fasting C-peptide to insulin and of the areas under the insulin to glucose curves during an OGTT. In total, 35% of participants were prepubertal, 72.6% had obesity class II, and 52.6% had mild SLD. Fasting ClI (nmol/pmol × 10−2) was significantly lower in pubertal [0.11 (0.08–0.14)] than in prepubertal individuals [0.12 (0.09–0.16)] and higher in class III [0.15 (0.11–0.16)] than in class I obesity [0.11 (0.09–0.14)]. OGTT ClI was highe...
This Position Statement updates the different components of the therapy of obesity (lifestyle int... more This Position Statement updates the different components of the therapy of obesity (lifestyle intervention, drugs, and surgery) in children and adolescents, previously reported in the consensus position statement on pediatric obesity of the Italian Society of Pediatric Endocrinology and Diabetology and the Italian Society of Pediatrics. Lifestyle intervention is the first step of treatment. In children older than 12 years, pharmacotherapy is the second step, and bariatric surgery is the third one, in selected cases. Novelties are available in the field of the medical treatment of obesity. In particular, new drugs demonstrated their efficacy and safety and have been approved in adolescents. Moreover, several randomized control trials with other drugs are in process and it is likely that some of them will become available in the future. The increase of the portfolio of treatment options for obesity in children and adolescents is promising for a more effective treatment of this disorder.
Prevalence of overweight and obesity in childhood has substantially increased worldwide in recent... more Prevalence of overweight and obesity in childhood has substantially increased worldwide in recent decades with children becoming obese at progressively younger ages. Obesity in children carries a wide range of serious complications, and contributes to an increased prevalence of cardiovascular risk factors such as hypertension, hypertrygliceridema, low high-density lipoprotein cholesterol (HDL), impaired glucose metabolism and early atherosclerotic changes not only in adulthood but since in very early pediatric age. In the ORIGIN study (Outcome Reduction with an Initial Glargine Intervention), cardiometabolic risk factors including fatty liver were already detectable in preschoolers at the onset of overweight/obesity despite short-term exposure to excess weight and fairly reduced insulin sensitivity. These facts together with the evidence that early cardiometabolic impairment reverts with lifestyle intervention in pediatric age, emphasize the need to start prevention of childhood obesity and screening of cardiometabolic co-morbities at the earliest stage with multidisciplinary strategies.
Background: One of the current methods to diagnose prediabetes and predict diabetes incidence is ... more Background: One of the current methods to diagnose prediabetes and predict diabetes incidence is based on 2-h plasma glucose (2-hPG) value following 75-g oral glucose tolerance test. Evidence demonstrates that 1-hour post-load plasma glucose (1-hPG) ≥ 155 mg/dl (8.6 mmol/L) in those with normal glucose tolerance at 2-hPG is highly predictive for T2D incidence. We conducted a health economic analysis to estimate long-term cost-effectiveness of using 1-hPG as compared to 2-hPG to screen and assess diabetes risk. Methods: The main outcome of the study was cost per quality-adjusted life-year (QALY) gained. We used a Monte Carlo-based Markov simulation model to simulate long-term effects of the two screening strategies on clinical and cost-effectiveness outcomes. The base case model included 20.000 simulated patients over 35-years. Transition probabilities were retrieved from landmark studies. Direct medical costs were sourced from the literature and inflated to 20Euros. Results: In the lifetime analysis, 1-hPG was projected to increase the number of years free from disease (2yr/patient) ; to delay the onset of T2D (1yr/patient) ; to reduce the incidence of T2D complications (0.6 Relative Risk/patient) and to increase the QALY gained (0.58/patient) . Though testing the 1-hPG resulted in higher initial costs owing to a larger number of preventive treatments, long-term diabetes and complications costs were reduced leading to -31,225,719.82€ saving over a lifetime as compared to 2-hPG. The incremental cost-effectiveness ratio was -8,214.7€ per each QALY gained for the overall population. Conclusions: Screening prediabetes by using 1h-PG is feasible and cost-effective resulting in QALYs gained and reduced costs. Notwithstanding the higher initial costs of 1-hPG compared to 2-hPG, due to the incremental number of preventive treatments, long-term diabetes and complications costs were reduced expecting an overall cost saving of -8,214.7€ per each QALY gained. Disclosure M.Andellini: None. M.Manco: None. M.Esposito: None. A.Tozzi: None. M.Bergman: None. M.Ritrovato: None.
Nutrition Metabolism and Cardiovascular Diseases, Jun 1, 2016
Corrigendum to "Comparison of non-HDL-cholesterol versus triglycerides-to-HDLcholesterol ratio in... more Corrigendum to "Comparison of non-HDL-cholesterol versus triglycerides-to-HDLcholesterol ratio in relation to cardiometabolic risk factors and preclinical organ damage in overweight/obese children: The CARITALY study" [Nutr Metab Cardiovasc Dis 25 (2015) 489e494]
Nutrition Metabolism and Cardiovascular Diseases, May 1, 2015
for the "CARdiometabolic risk factors in overweight and obese children in ITALY" (CARITALY) Study... more for the "CARdiometabolic risk factors in overweight and obese children in ITALY" (CARITALY) Study Group 1
Users may download and print one copy of any publication from the public portal for the purpose... more Users may download and print one copy of any publication from the public portal for the purpose of private study or research. You may not further distribute the material or use it for any profit-making activity or commercial gain You may freely distribute the URL identifying the publication in the public portal If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim.
The present opinion deals with the re-evaluation of polyvinylpyrrolidone (E 1201, PVP) and polyvi... more The present opinion deals with the re-evaluation of polyvinylpyrrolidone (E 1201, PVP) and polyvinylpolypyrrolidone (E 1202, PVPP) when used as food additives. One request for extension of use of PVP (E 1201) in foods for special medical purposes was also considered in this assessment. The Panel followed the conceptual framework under Commission Regulation (EU) No 257/2010 and considered that: the exposure assessment was based on the reported use and use levels (one food category out of the two food categories in which PVP and PVPP are authorised); the 95th percentile of exposure to PVP and PVPP of maximally 23.7 and 25 mg/kg body weight (bw) per day in children, respectively, was overestimated, because it was assumed that 100% of the food supplements consumed contained PVP or PVPP at the maximum reported use levels; the extension of use of PVP (E 1201) to foods for special medical purposes (FC 13.2) would result in an exposure of PVP of 4.3 mg/kg bw per day for children; the absorption of PVP and PVPP is very low; sufficient toxicity data were available for PVP; there is no concern with respect to the genotoxicity of PVP and PVPP; no carcinogenic effects were reported in carcinogenicity studies in rats at a dose of 2,500 mg PVP/kg bw per day, the highest dose tested; there is no need for chronic toxicity/carcinogenicity data for PVPP for the safety assessment of PVPP given the chemical similarity between PVP and PVPP, and the lack of adverse effects in the available repeated dose toxicity studies. Therefore, the Panel concluded that there is no need for numerical acceptable daily intakes (ADIs) for PVP and PVPP, and that there is no safety concern for the reported uses and use levels of PVP and PVPP as food additives. The Panel further concluded that the proposed extension of use is not expected to be of safety concern at the proposed maximum permitted level (MPL) and recommended consumption level.
The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the... more The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of Sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) as food additives. The Scientific Committee for Food (SCF) assigned these food additives together with other aluminiumcontaining food additives a provisional tolerable weekly intake (PTWI) of 7 mg aluminium/kg body weight (bw). In 2008, EFSA established a tolerable weekly intake (TWI) of 1 mg aluminium/kg bw per week. Sodium aluminium silicate was shown in rats to be absorbed to a limited extent at 0.12 AE 0.011%. The Panel considered that potassium aluminium silicate would be absorbed and become systemically available similarly to sodium aluminium silicate. No information on the physicochemical characterisation of sodium aluminium silicate and potassium aluminium silicate when used as food additives has been submitted and only very limited toxicological data were available for sodium aluminium silicate. Exposure to E 554 was calculated based on the reported use levels in food supplements. Exposure to aluminium from this use of E 554 was calculated to exceed the TWI for aluminium. Based on the data provided by interested business operators, the Panel considered that E 555 is not being used as a carrier, but as an inseparable component of 'potassium aluminium silicatebased pearlescent pigments'. The Panel calculated the regulatory maximum exposure to E 555 as a carrier for titanium dioxide (E 171) and iron oxides and hydroxides (E 172). Exposure to aluminium from this single use at the maximum permitted level could theoretically far exceed the TWI. Considering that only very limited toxicological data and insufficient information on the physicochemical characterisation of both food additives were available, the Panel concluded that the safety of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) could not be assessed.
The present opinion deals with the re-evaluation of thaumatin (E 957) when used as a food additiv... more The present opinion deals with the re-evaluation of thaumatin (E 957) when used as a food additive. Thaumatin is a natural plant protein, consisting of thaumatin I and thaumatin II proteins together with minor amounts of plant constituents, obtained by acidic aqueous extraction of the arils of the fruit of Thaumatococcus daniellii plant. The Panel followed the conceptual framework for the risk assessment of certain food additives and considered that thaumatin is a digestible protein; adequate exposure estimates were available; there was no concern with respect to the genotoxicity; no conclusion on oral allergenicity could be drawn from the available human data; no adverse effects were observed in sub-chronic toxicity studies in rats and dogs at the highest dose tested of up 5,200 and 1,476 mg/kg bodyweight (bw) per day, respectively, and in a prenatal developmental toxicity study up to 2,000 mg/kg bw per day; moderate confidence in the body of evidence supported the absence of association between exposure to thaumatin and adverse health outcomes. Therefore, the Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for thaumatin (E 957) and, based on a margin of safety (MOS) of 5,417, considered to be an underestimate and derived using the highest 95th percentile (P95) exposure of 0.48 mg/kg bw per day in consumers only, there is no safety concern for thaumatin (E 957) at the regulatory maximum level exposure assessment scenario, which was considered the most appropriate. The Panel recommended that European Commission considers introducing in the EU specifications for thaumatin (E 957) a new specification limit for the minimum combined content of thaumatin I and II proteins in E 957, a specification limit for yeast, mould counts and Salmonella spp and lowering the existing maximum limit for arsenic along with the inclusion of maximum limits for mercury and cadmium.
The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safet... more The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of crosslinked polyacrylic acid polymers (carbomer) proposed for use as food additive in solid and liquid food supplements. Carbomer is formed from the monomer, acrylic acid, which is polymerised and crosslinked with allyl pentaerythritol (APE). The polymers are synthesised in ethyl acetate using as free-radical polymerisation initiator. In vivo data showed no evidence for systemic availability or biotransformation of carbomer. Carbomer does not raise a concern regarding genotoxicity. Considering the available data set, the Panel derived an acceptable daily intake (ADI) of 190 mg/kg body weight (bw) per day based on a no observed adverse effect level (NOAEL) of 1,500 mg/kg bw per day from a sub-chronic 13-week study in rat, applying a compound specific uncertainty factor (UF) of 8. At the proposed maximum use levels, the exposure estimates ranged at the mean from 1.1 to 90.2 mg/kg bw per day and at the p95 from 12.5 to 237.4 mg/kg bw per day. At the proposed typical use level, the exposure estimates ranged at the mean from 0.7 to 60.2 mg/kg bw per day and at the p95 from 10.3 to 159.5 mg/kg bw per day. The Panel noted that the maximum proposed use levels would result in exposure estimates close to or above the ADI. The Panel also noted that level of exposure to carbomer from its proposed use is likely to be an overestimation. Taking a conservative approach, the Panel considered that exposure to carbomer would not give rise to a safety concern if the proposed maximum use level for solid food supplements is lowered to the typical use level reported by the applicant.
Following a request from the European Commission, EFSA developed updated scientific guidance to a... more Following a request from the European Commission, EFSA developed updated scientific guidance to assist applicants in the preparation of applications on smoke flavouring primary products. This guidance describes the scientific data to be included in the applications for the authorisation of new smoke flavouring primary products, as well as for the renewal or for the modification of existing authorisations, submitted respectively under Articles 7, 12 and 11 of Regulation (EC) No 2065/2003. Information to be provided in all applications relates to: the characterisation of the primary product, including the description of the source materials, manufacturing process, chemical composition, specifications and stability; the proposed uses and use levels and the assessment of the dietary exposure; the safety data, including information on the genotoxic potential of the identified components and of the unidentified fraction of the primary product, toxicological data other than genotoxicity and information on the safety for the environment. For the toxicological studies a tiered approach is applied, for which the testing requirements, key issues and triggers are described. A description of the standard uncertainties relevant for the evaluation of primary products and how these are considered in the standardised risk assessment procedure is also included. The applicant should generate the data requested in each section to support the safety assessment of the smoke flavouring primary product. On the basis of the submitted data, EFSA will assess the safety of the primary product and conclude whether or not it presents risks to human health and to the environment under the proposed conditions of use.
The present opinion deals with an updated safety assessment of the food additive titanium dioxide... more The present opinion deals with an updated safety assessment of the food additive titanium dioxide (E 171) based on new relevant scientific evidence considered by the Panel to be reliable, including data obtained with TiO 2 nanoparticles (NPs) and data from an extended one-generation reproductive toxicity (EOGRT) study. Less than 50% of constituent particles by number in E 171 have a minimum external dimension < 100 nm. In addition, the Panel noted that constituent particles < 30 nm amounted to less than 1% of particles by number. The Panel therefore considered that studies with TiO 2 NPs < 30 nm were of limited relevance to the safety assessment of E 171. The Panel concluded that although gastrointestinal absorption of TiO 2 particles is low, they may accumulate in the body. Studies on general and organ toxicity did not indicate adverse effects with either E 171 up to a dose of 1,000 mg/kg body weight (bw) per day or with TiO 2 NPs (> 30 nm) up to the highest dose tested of 100 mg/kg bw per day. No effects on reproductive and developmental toxicity were observed up to a dose of 1,000 mg E 171/kg bw per day, the highest dose tested in the EOGRT study. However, observations of potential immunotoxicity and inflammation with E 171 and potential neurotoxicity with TiO 2 NPs, together with the potential induction of aberrant crypt foci with E 171, may indicate adverse effects. With respect to genotoxicity, the Panel concluded that TiO 2 particles have the potential to induce DNA strand breaks and chromosomal damage, but not gene mutations. No clear correlation was observed between the physico-chemical properties of TiO 2 particles and the outcome of either in vitro or in vivo genotoxicity assays. A concern for genotoxicity of TiO 2 particles that may be present in E 171 could therefore not be ruled out. Several modes of action for the genotoxicity may operate in parallel and the relative contributions of different molecular mechanisms elicited by TiO 2 particles are not known. There was uncertainty as to whether a threshold mode of action could be assumed. In addition, a cutoff value for TiO 2 particle size with respect to genotoxicity could not be identified. No appropriately designed study was available to investigate the potential carcinogenic effects of TiO 2 NPs. Based on all the evidence available, a concern for genotoxicity could not be ruled out, and given the many uncertainties, the Panel concluded that E 171 can no longer be considered as safe when used as a food additive.
Background: Perilipin (Plin) 2 regulates intracellular lipid metabolism in macrophages, thus play... more Background: Perilipin (Plin) 2 regulates intracellular lipid metabolism in macrophages, thus playing a role in atherosclerosis. Aim of the study was to evaluate whether dysregulation of Plin2 is involved in the onset of the early atherosclerosis seen in children with obesity and to rule out mechanisms of dysregulation.Methods: We enrolled 63 children with overweight/obesity and 21 age- and sex-matched normal-weight controls; we evaluated carotid intima media thickness (cIMT). We determined mRNA expression of Plin2 and proteasome subunits (PSMD3, PSMC4) by RealTime PCR and protein expression of Plin2, LAMP2A and Hsc70 by western blot analysis. We performed transient LAMP2A downregulation by siRNA. We quantified intracellular lipids in monocytes by Nile Red staining and flow cytometry analysis.Results: Levels of Plin2 protein were significantly higher in obese children than in normal-weight controls and correlated with cIMT in children with obesity after adjusting for confounders. Acc...
An amendment to this paper has been published and can be accessed via a link at the top of the pa... more An amendment to this paper has been published and can be accessed via a link at the top of the paper.
Opinion on the re-evaluation of lecithins (E 322) as a food additive in foods for infants below 1... more Opinion on the re-evaluation of lecithins (E 322) as a food additive in foods for infants below 16 weeks of age and follow-up of its re-evaluation as food additive for uses in foods for all population groups EFSA Panel on Food Additives and Flavourings (FAF),
Opinion on the re-evaluation of pectin (E 440i) and amidated pectin (E 440ii) as food additives i... more Opinion on the re-evaluation of pectin (E 440i) and amidated pectin (E 440ii) as food additives in foods for infants below 16 weeks of age and follow-up of their re-evaluation as food additives for uses in foods for all population groups EFSA Panel on Food Additives and Flavourings (FAF),
No data are available on insulin clearance (ClI) trends during the pubertal transition. The aim o... more No data are available on insulin clearance (ClI) trends during the pubertal transition. The aim of this study was to investigate in 973 youths with obesity whether ClI in fasting and post-oral glucose challenge (OGTT) conditions varies at the pubertal transition in relation to the severity of obesity and the presence of steatosis liver disease (SLD). The severity of obesity was graded according to the Centers for Disease Control. SLD was graded as absent, mild and severe based on alanine amino transferase levels. ClI was defined as the molar ratio of fasting C-peptide to insulin and of the areas under the insulin to glucose curves during an OGTT. In total, 35% of participants were prepubertal, 72.6% had obesity class II, and 52.6% had mild SLD. Fasting ClI (nmol/pmol × 10−2) was significantly lower in pubertal [0.11 (0.08–0.14)] than in prepubertal individuals [0.12 (0.09–0.16)] and higher in class III [0.15 (0.11–0.16)] than in class I obesity [0.11 (0.09–0.14)]. OGTT ClI was highe...
This Position Statement updates the different components of the therapy of obesity (lifestyle int... more This Position Statement updates the different components of the therapy of obesity (lifestyle intervention, drugs, and surgery) in children and adolescents, previously reported in the consensus position statement on pediatric obesity of the Italian Society of Pediatric Endocrinology and Diabetology and the Italian Society of Pediatrics. Lifestyle intervention is the first step of treatment. In children older than 12 years, pharmacotherapy is the second step, and bariatric surgery is the third one, in selected cases. Novelties are available in the field of the medical treatment of obesity. In particular, new drugs demonstrated their efficacy and safety and have been approved in adolescents. Moreover, several randomized control trials with other drugs are in process and it is likely that some of them will become available in the future. The increase of the portfolio of treatment options for obesity in children and adolescents is promising for a more effective treatment of this disorder.
Prevalence of overweight and obesity in childhood has substantially increased worldwide in recent... more Prevalence of overweight and obesity in childhood has substantially increased worldwide in recent decades with children becoming obese at progressively younger ages. Obesity in children carries a wide range of serious complications, and contributes to an increased prevalence of cardiovascular risk factors such as hypertension, hypertrygliceridema, low high-density lipoprotein cholesterol (HDL), impaired glucose metabolism and early atherosclerotic changes not only in adulthood but since in very early pediatric age. In the ORIGIN study (Outcome Reduction with an Initial Glargine Intervention), cardiometabolic risk factors including fatty liver were already detectable in preschoolers at the onset of overweight/obesity despite short-term exposure to excess weight and fairly reduced insulin sensitivity. These facts together with the evidence that early cardiometabolic impairment reverts with lifestyle intervention in pediatric age, emphasize the need to start prevention of childhood obesity and screening of cardiometabolic co-morbities at the earliest stage with multidisciplinary strategies.
Background: One of the current methods to diagnose prediabetes and predict diabetes incidence is ... more Background: One of the current methods to diagnose prediabetes and predict diabetes incidence is based on 2-h plasma glucose (2-hPG) value following 75-g oral glucose tolerance test. Evidence demonstrates that 1-hour post-load plasma glucose (1-hPG) ≥ 155 mg/dl (8.6 mmol/L) in those with normal glucose tolerance at 2-hPG is highly predictive for T2D incidence. We conducted a health economic analysis to estimate long-term cost-effectiveness of using 1-hPG as compared to 2-hPG to screen and assess diabetes risk. Methods: The main outcome of the study was cost per quality-adjusted life-year (QALY) gained. We used a Monte Carlo-based Markov simulation model to simulate long-term effects of the two screening strategies on clinical and cost-effectiveness outcomes. The base case model included 20.000 simulated patients over 35-years. Transition probabilities were retrieved from landmark studies. Direct medical costs were sourced from the literature and inflated to 20Euros. Results: In the lifetime analysis, 1-hPG was projected to increase the number of years free from disease (2yr/patient) ; to delay the onset of T2D (1yr/patient) ; to reduce the incidence of T2D complications (0.6 Relative Risk/patient) and to increase the QALY gained (0.58/patient) . Though testing the 1-hPG resulted in higher initial costs owing to a larger number of preventive treatments, long-term diabetes and complications costs were reduced leading to -31,225,719.82€ saving over a lifetime as compared to 2-hPG. The incremental cost-effectiveness ratio was -8,214.7€ per each QALY gained for the overall population. Conclusions: Screening prediabetes by using 1h-PG is feasible and cost-effective resulting in QALYs gained and reduced costs. Notwithstanding the higher initial costs of 1-hPG compared to 2-hPG, due to the incremental number of preventive treatments, long-term diabetes and complications costs were reduced expecting an overall cost saving of -8,214.7€ per each QALY gained. Disclosure M.Andellini: None. M.Manco: None. M.Esposito: None. A.Tozzi: None. M.Bergman: None. M.Ritrovato: None.
Nutrition Metabolism and Cardiovascular Diseases, Jun 1, 2016
Corrigendum to "Comparison of non-HDL-cholesterol versus triglycerides-to-HDLcholesterol ratio in... more Corrigendum to "Comparison of non-HDL-cholesterol versus triglycerides-to-HDLcholesterol ratio in relation to cardiometabolic risk factors and preclinical organ damage in overweight/obese children: The CARITALY study" [Nutr Metab Cardiovasc Dis 25 (2015) 489e494]
Nutrition Metabolism and Cardiovascular Diseases, May 1, 2015
for the "CARdiometabolic risk factors in overweight and obese children in ITALY" (CARITALY) Study... more for the "CARdiometabolic risk factors in overweight and obese children in ITALY" (CARITALY) Study Group 1
Users may download and print one copy of any publication from the public portal for the purpose... more Users may download and print one copy of any publication from the public portal for the purpose of private study or research. You may not further distribute the material or use it for any profit-making activity or commercial gain You may freely distribute the URL identifying the publication in the public portal If you believe that this document breaches copyright please contact us providing details, and we will remove access to the work immediately and investigate your claim.
The present opinion deals with the re-evaluation of polyvinylpyrrolidone (E 1201, PVP) and polyvi... more The present opinion deals with the re-evaluation of polyvinylpyrrolidone (E 1201, PVP) and polyvinylpolypyrrolidone (E 1202, PVPP) when used as food additives. One request for extension of use of PVP (E 1201) in foods for special medical purposes was also considered in this assessment. The Panel followed the conceptual framework under Commission Regulation (EU) No 257/2010 and considered that: the exposure assessment was based on the reported use and use levels (one food category out of the two food categories in which PVP and PVPP are authorised); the 95th percentile of exposure to PVP and PVPP of maximally 23.7 and 25 mg/kg body weight (bw) per day in children, respectively, was overestimated, because it was assumed that 100% of the food supplements consumed contained PVP or PVPP at the maximum reported use levels; the extension of use of PVP (E 1201) to foods for special medical purposes (FC 13.2) would result in an exposure of PVP of 4.3 mg/kg bw per day for children; the absorption of PVP and PVPP is very low; sufficient toxicity data were available for PVP; there is no concern with respect to the genotoxicity of PVP and PVPP; no carcinogenic effects were reported in carcinogenicity studies in rats at a dose of 2,500 mg PVP/kg bw per day, the highest dose tested; there is no need for chronic toxicity/carcinogenicity data for PVPP for the safety assessment of PVPP given the chemical similarity between PVP and PVPP, and the lack of adverse effects in the available repeated dose toxicity studies. Therefore, the Panel concluded that there is no need for numerical acceptable daily intakes (ADIs) for PVP and PVPP, and that there is no safety concern for the reported uses and use levels of PVP and PVPP as food additives. The Panel further concluded that the proposed extension of use is not expected to be of safety concern at the proposed maximum permitted level (MPL) and recommended consumption level.
The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the... more The Panel on Food Additives and Flavourings (FAF) provided a scientific opinion re-evaluating the safety of Sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) as food additives. The Scientific Committee for Food (SCF) assigned these food additives together with other aluminiumcontaining food additives a provisional tolerable weekly intake (PTWI) of 7 mg aluminium/kg body weight (bw). In 2008, EFSA established a tolerable weekly intake (TWI) of 1 mg aluminium/kg bw per week. Sodium aluminium silicate was shown in rats to be absorbed to a limited extent at 0.12 AE 0.011%. The Panel considered that potassium aluminium silicate would be absorbed and become systemically available similarly to sodium aluminium silicate. No information on the physicochemical characterisation of sodium aluminium silicate and potassium aluminium silicate when used as food additives has been submitted and only very limited toxicological data were available for sodium aluminium silicate. Exposure to E 554 was calculated based on the reported use levels in food supplements. Exposure to aluminium from this use of E 554 was calculated to exceed the TWI for aluminium. Based on the data provided by interested business operators, the Panel considered that E 555 is not being used as a carrier, but as an inseparable component of 'potassium aluminium silicatebased pearlescent pigments'. The Panel calculated the regulatory maximum exposure to E 555 as a carrier for titanium dioxide (E 171) and iron oxides and hydroxides (E 172). Exposure to aluminium from this single use at the maximum permitted level could theoretically far exceed the TWI. Considering that only very limited toxicological data and insufficient information on the physicochemical characterisation of both food additives were available, the Panel concluded that the safety of sodium aluminium silicate (E 554) and potassium aluminium silicate (E 555) could not be assessed.
The present opinion deals with the re-evaluation of thaumatin (E 957) when used as a food additiv... more The present opinion deals with the re-evaluation of thaumatin (E 957) when used as a food additive. Thaumatin is a natural plant protein, consisting of thaumatin I and thaumatin II proteins together with minor amounts of plant constituents, obtained by acidic aqueous extraction of the arils of the fruit of Thaumatococcus daniellii plant. The Panel followed the conceptual framework for the risk assessment of certain food additives and considered that thaumatin is a digestible protein; adequate exposure estimates were available; there was no concern with respect to the genotoxicity; no conclusion on oral allergenicity could be drawn from the available human data; no adverse effects were observed in sub-chronic toxicity studies in rats and dogs at the highest dose tested of up 5,200 and 1,476 mg/kg bodyweight (bw) per day, respectively, and in a prenatal developmental toxicity study up to 2,000 mg/kg bw per day; moderate confidence in the body of evidence supported the absence of association between exposure to thaumatin and adverse health outcomes. Therefore, the Panel concluded that there is no need for a numerical acceptable daily intake (ADI) for thaumatin (E 957) and, based on a margin of safety (MOS) of 5,417, considered to be an underestimate and derived using the highest 95th percentile (P95) exposure of 0.48 mg/kg bw per day in consumers only, there is no safety concern for thaumatin (E 957) at the regulatory maximum level exposure assessment scenario, which was considered the most appropriate. The Panel recommended that European Commission considers introducing in the EU specifications for thaumatin (E 957) a new specification limit for the minimum combined content of thaumatin I and II proteins in E 957, a specification limit for yeast, mould counts and Salmonella spp and lowering the existing maximum limit for arsenic along with the inclusion of maximum limits for mercury and cadmium.
The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safet... more The EFSA Panel on Food Additives and Flavourings (FAF) provides a scientific opinion on the safety of crosslinked polyacrylic acid polymers (carbomer) proposed for use as food additive in solid and liquid food supplements. Carbomer is formed from the monomer, acrylic acid, which is polymerised and crosslinked with allyl pentaerythritol (APE). The polymers are synthesised in ethyl acetate using as free-radical polymerisation initiator. In vivo data showed no evidence for systemic availability or biotransformation of carbomer. Carbomer does not raise a concern regarding genotoxicity. Considering the available data set, the Panel derived an acceptable daily intake (ADI) of 190 mg/kg body weight (bw) per day based on a no observed adverse effect level (NOAEL) of 1,500 mg/kg bw per day from a sub-chronic 13-week study in rat, applying a compound specific uncertainty factor (UF) of 8. At the proposed maximum use levels, the exposure estimates ranged at the mean from 1.1 to 90.2 mg/kg bw per day and at the p95 from 12.5 to 237.4 mg/kg bw per day. At the proposed typical use level, the exposure estimates ranged at the mean from 0.7 to 60.2 mg/kg bw per day and at the p95 from 10.3 to 159.5 mg/kg bw per day. The Panel noted that the maximum proposed use levels would result in exposure estimates close to or above the ADI. The Panel also noted that level of exposure to carbomer from its proposed use is likely to be an overestimation. Taking a conservative approach, the Panel considered that exposure to carbomer would not give rise to a safety concern if the proposed maximum use level for solid food supplements is lowered to the typical use level reported by the applicant.
Following a request from the European Commission, EFSA developed updated scientific guidance to a... more Following a request from the European Commission, EFSA developed updated scientific guidance to assist applicants in the preparation of applications on smoke flavouring primary products. This guidance describes the scientific data to be included in the applications for the authorisation of new smoke flavouring primary products, as well as for the renewal or for the modification of existing authorisations, submitted respectively under Articles 7, 12 and 11 of Regulation (EC) No 2065/2003. Information to be provided in all applications relates to: the characterisation of the primary product, including the description of the source materials, manufacturing process, chemical composition, specifications and stability; the proposed uses and use levels and the assessment of the dietary exposure; the safety data, including information on the genotoxic potential of the identified components and of the unidentified fraction of the primary product, toxicological data other than genotoxicity and information on the safety for the environment. For the toxicological studies a tiered approach is applied, for which the testing requirements, key issues and triggers are described. A description of the standard uncertainties relevant for the evaluation of primary products and how these are considered in the standardised risk assessment procedure is also included. The applicant should generate the data requested in each section to support the safety assessment of the smoke flavouring primary product. On the basis of the submitted data, EFSA will assess the safety of the primary product and conclude whether or not it presents risks to human health and to the environment under the proposed conditions of use.
The present opinion deals with an updated safety assessment of the food additive titanium dioxide... more The present opinion deals with an updated safety assessment of the food additive titanium dioxide (E 171) based on new relevant scientific evidence considered by the Panel to be reliable, including data obtained with TiO 2 nanoparticles (NPs) and data from an extended one-generation reproductive toxicity (EOGRT) study. Less than 50% of constituent particles by number in E 171 have a minimum external dimension < 100 nm. In addition, the Panel noted that constituent particles < 30 nm amounted to less than 1% of particles by number. The Panel therefore considered that studies with TiO 2 NPs < 30 nm were of limited relevance to the safety assessment of E 171. The Panel concluded that although gastrointestinal absorption of TiO 2 particles is low, they may accumulate in the body. Studies on general and organ toxicity did not indicate adverse effects with either E 171 up to a dose of 1,000 mg/kg body weight (bw) per day or with TiO 2 NPs (> 30 nm) up to the highest dose tested of 100 mg/kg bw per day. No effects on reproductive and developmental toxicity were observed up to a dose of 1,000 mg E 171/kg bw per day, the highest dose tested in the EOGRT study. However, observations of potential immunotoxicity and inflammation with E 171 and potential neurotoxicity with TiO 2 NPs, together with the potential induction of aberrant crypt foci with E 171, may indicate adverse effects. With respect to genotoxicity, the Panel concluded that TiO 2 particles have the potential to induce DNA strand breaks and chromosomal damage, but not gene mutations. No clear correlation was observed between the physico-chemical properties of TiO 2 particles and the outcome of either in vitro or in vivo genotoxicity assays. A concern for genotoxicity of TiO 2 particles that may be present in E 171 could therefore not be ruled out. Several modes of action for the genotoxicity may operate in parallel and the relative contributions of different molecular mechanisms elicited by TiO 2 particles are not known. There was uncertainty as to whether a threshold mode of action could be assumed. In addition, a cutoff value for TiO 2 particle size with respect to genotoxicity could not be identified. No appropriately designed study was available to investigate the potential carcinogenic effects of TiO 2 NPs. Based on all the evidence available, a concern for genotoxicity could not be ruled out, and given the many uncertainties, the Panel concluded that E 171 can no longer be considered as safe when used as a food additive.
Background: Perilipin (Plin) 2 regulates intracellular lipid metabolism in macrophages, thus play... more Background: Perilipin (Plin) 2 regulates intracellular lipid metabolism in macrophages, thus playing a role in atherosclerosis. Aim of the study was to evaluate whether dysregulation of Plin2 is involved in the onset of the early atherosclerosis seen in children with obesity and to rule out mechanisms of dysregulation.Methods: We enrolled 63 children with overweight/obesity and 21 age- and sex-matched normal-weight controls; we evaluated carotid intima media thickness (cIMT). We determined mRNA expression of Plin2 and proteasome subunits (PSMD3, PSMC4) by RealTime PCR and protein expression of Plin2, LAMP2A and Hsc70 by western blot analysis. We performed transient LAMP2A downregulation by siRNA. We quantified intracellular lipids in monocytes by Nile Red staining and flow cytometry analysis.Results: Levels of Plin2 protein were significantly higher in obese children than in normal-weight controls and correlated with cIMT in children with obesity after adjusting for confounders. Acc...
An amendment to this paper has been published and can be accessed via a link at the top of the pa... more An amendment to this paper has been published and can be accessed via a link at the top of the paper.
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Papers by Melania Manco